Richard Denison, Ph.D., is a Lead Senior Scientist.
[pullquote]“The agency’s goal is to allow the commercialization of products,” said EPA associate deputy assistant administrator for new chemicals Lynn Dekleva.[/pullquote]Readers of this blog know that EDF is no fan of how the Trump EPA has implemented – in our view, twisted – the 2016 reforms made to the review process for new chemicals under the Toxic Substances Control Act (TSCA). Decision after decision over the last 3.5 years under this administration has undercut public health and benefitted industry interests, despite some noble efforts by career staff to chart a better course. In recent weeks the Trump EPA’s intentions have been even more clearly revealed, thanks to the trade press’s reporting of EPA political appointees’ comments delivered to industry audiences. That’s what this post is about.
EPA is prioritizing speed to market above all else, and to do so it has made weakening changes to every aspect of its new chemical reviews:
- avoiding regulating risks that new chemicals pose to workers even when those risks exceed EPA risk benchmarks, sometimes by orders of magnitude;
- making it far harder for EPA to identify an activity associated with a new chemical as “reasonably foreseen,” by effectively redefining the statutory term to compel agency staff to demonstrate the activity is highly likely to occur;
- failing to evaluate risks of a reasonably foreseen use or other activity, even where one is identified, in combination with intended uses as TSCA requires, and instead relegating it at best to a future review isolated from the first one;
- avoiding imposing testing requirements on new chemicals at all costs despite major data gaps, flying in the face of a key reform to TSCA;
- repeatedly distorting TSCA’s sole provision referencing “innovation” to erase its emphasis on ensuring new chemicals do not present risks to health and the environment;
- failing to conduct timely review of the myriad confidentiality claims in new chemical notices, thereby denying the public access to health and safety information; and
- continuing to deny the public timely access to information on new chemicals and the basis for EPA’s decisions about them, even as the agency makes it easier for companies to know exactly where their chemicals are in the review process.
EPA has couched these moves as being responsive to the concerns of “stakeholders” and as “enhancing transparency,” with nary a nod to their virtually one-sided nature.
But in recent weeks the Trump EPA’s intentions have been clearly revealed, thanks to the trade press’s reporting of EPA political appointees’ comments, made most recently in a series of pay-per-view weekly webinars sponsored by the American Chemistry Council, held in lieu of its annual GlobalChem conference. While that conference has always featured a steady stream of EPA staff seeking to account for their actions to an industry audience, the comments dribbling out over the last few weeks attributed to EPA speakers have been particularly illuminating.
Speed to market is now job one at EPA
Since the day TSCA was reformed in 2016, industry has been demanding that EPA speed up its reviews (and approvals) of new chemicals. Many of the changes the Trump EPA has made have been to respond to those relentless demands. And it has become the top priority for the new chemicals program.
Dr. Lynn Dekleva, associate deputy assistant administrator for new chemicals, made that clear in her remarks on one of the ACC webinars. Referring to the statute’s 90-day period for EPA generally to conduct its review of a new chemical, Inside EPA reported that Dekleva told the industry EPA “has a ‘shared commitment’ in the ‘drive to 90,’ which is the agency’s motto in addressing the PMN [premanufacture notice] backlog. ‘We can drive this shared commitment to 90,’ Dekleva told industry participants of the ACC webinar.”
Readers may recall that Dekleva came to EPA in August 2019 directly from DuPont, where her job was to expedite EPA approval of DuPont’s new chemicals. Now she’s doing that from the inside, only no longer just for DuPont.
Chemical Watch reported that Dekleva went on to tell the industry EPA continues to look “for ways to ‘lean’ both the risk evaluation and risk management phases of its new chemicals reviews. This work entails evaluating each of the steps in the process, identifying the root causes for delays and then coming up with mitigation activities. ‘These process improvements have resulted in an increase in speed through the process, and we’re still using ‘lean activities’ to target additional bottlenecks,’ she said.”
“Mitigation activities” at EPA used to mean steps to be taken to reduce health and environmental impacts. Now it means steps to be taken to get new chemical approvals out the door more quickly.
EPA reassures industry it need not worry about “unilateral orders” EPA will be issuing
Dekleva and her boss, Alexandra Dunn, assistant administrator for the EPA toxics office, have been giving the industry multiple heads-up starting in March that EPA plans to issue “unilateral orders” for certain new chemicals, the reviews of which have stalled. Despite the fact that TSCA gives EPA direct authority to issue such orders, EPA virtually never has used it. Instead, EPA has opted for so-called “consent orders” – a term never mentioned in TSCA – it negotiates with companies, who are thus given a say in what conditions will apply to EPA’s approval of their new chemicals. That two-party system has long been a black box, with the public completely locked out of the process – no ability to know until after the fact what EPA’s review turned up or what was up for negotiation; no opportunity for input; no timely access to information on the new chemicals being reviewed and the basis for EPA’s decisions about them; and huge swaths of the content of documents that are publicly released blacked out, claimed “confidential.”
Given that EPA is increasingly rarely pursuing orders of any sort these days, EPA was clearly worried that the idea that EPA might simply issue an order without negotiating its terms with a company could send shock waves through the industry. So it’s gone out of its way to reassure the industry that no real change is afoot.
In March, Chemical Watch reported that Dunn reassured companies: “We are going to find a handful of those cases – that are rare, and I do emphasise rare, but appropriate – where that company has essentially abandoned the submission, or abandoned the negotiation with EPA. And we don’t mean just over a couple of days, we mean like over months.”
Dekleva echoed this sentiment more recently, telling the ACC webinar audience, according to Inside EPA, that “the moves will be done carefully to target unresponsive companies in a way that is being supported by industry. ‘We want to be careful that we’re applying it as conservatively as possible.’”
The real reason behind the move? To try to reduce the infamous “backlog” that EPA used to justify the changes it has made but that stubbornly persists despite the changes.
We’ll see what these unilateral orders actually do. If there was ever a case for EPA to simply block market access to a new chemical – an unresponsive company that refuses to provide EPA with even the minimal information EPA uses these days to declare new chemicals safe – this would be it. If instead EPA still approves market entry, subject only to some conditions, that would seem to reward such a company, which at best has clearly lost interest in marketing its chemical.
A new mission statement for the EPA new chemicals program?
Noticeably absent from the comments reported above, and remarkably rare in EPA’s discussions of its new chemicals program over the past several years, is any reference to that actual purpose of TSCA’s requirement that EPA review and make an affirmative decision on each new chemical: to ensure protection of health and the environment.
At the ACC webinar, Dekleva seems to have summed up the Trump EPA’s new objective, as reported by Bloomberg Law’s Environment and Energy Report:
“The agency’s goal is to allow the commercialization of products,” Dekleva said.